We are looking for a candidate with solid work experience, a great attitude, and strong communicator who is looking for a long-term opportunity. They must be familiar with working in a regulated environment (Med Device / Pharma). Attention to detail is paramount for this role as they will be managing and organizing all company documents and records.
Responsibilities • The Quality Assurance Coordinator performs ocular and tissue donor record quality assurance review in compliance with org, FDA, EBAA, and AATB policies, procedures, regulations, and standards • This position facilitates requests from hospitals, medical examiners, coroner's facilities, or other external agencies to ensure complete donor records are obtained • Receives, compiles, and prepares the donor record for eligibility review and signature of donor records as applicable • As needed, meets with the Tissue Bank Medical Director(s) to review, and answer questions pertaining to the information and documentation within the donor record • Facilitates requests from hospital/medical examiner or corner's facility (or other external entities as requested) for data and medical record documentation in accordance with regulatory and accreditation entity requirements as well as internal Policy and procedure • Receive, compile, and places appropriate documents within the donor records, when necessary, as required by sharing of donor information • Recognizes and reports trends and opportunities for improvement related to donor records and OPO statistics to the Quality Assurance Manager • Participates in required quality training and educational growth to ensure staff is competent, compliant, and trained in quality related tasks with all regulatory and accreditation entities and internal standards • Responsible for supporting the use of systems within the Quality Management System and improvement initiatives within the quality department • Maintains open verbal and written communication with org and location Quality Department teams and all other applicable departments as it relates to job functions and tasks • If applicable, answers donor recovery screening questions as needed on an on-call basis on behalf of the organization • Assists in training and mentoring of new Quality Assurance Coordinators • Assist in providing initial, periodic and re-training of quality documentation for ocular and tissue donor related activities for quality and recovery staff • Acts as a role model for Quality Departments by supporting, reinforcing, and exhibiting behaviors consistent with the core values • Performs other related duties as assigned
Required Qualifications:
Bachelor's degree in business administration, information management, or related field preferred or high school diploma/equivalent with 3 years relevant work experience in a regulated environment (Med Device/Pharma).
Proven experience in quality assurance/quality control, document control, records management, or related roles.
Strong attention to detail and accuracy in document handling and data entry.
Proficiency in document management software and the Microsoft Office suite.
Excellent organizational and time management skills, with the ability to prioritize tasks effectively.
Strong communication and interpersonal skills, facilitating effective collaboration with cross-functional teams.
Knowledge of regulatory requirements and standards related to document control (e.g., ISO 9001, FDA regulations) is advantageous.
Ability to maintain confidentiality and handle sensitive information with discretion.